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FDA Hears Evidence, Arguments for Standardized Talc Testing

FDA Hears Evidence, Arguments for Standardized Talc Testing

Posted on Thursday, March 5th, 2020

Scientists and other experts say talc asbestos regulations are needed.

Lawsuit News from OnderLaw

Thursday, March 5, 2020 – For the first time in 50 years, the U.S. Food and Drug Administration (FDA) held a public hearing to discuss standardizing testing methods and classification of asbestos found in talc use in hundreds of cosmetic products, including talcum powder.

Decades of studies and documentation show that asbestos, a known carcinogen, is inherent in talc supplies. Talc and asbestos are created under the same geologic conditions, and they are nearly always found together in the mines where talc is harvested.

Separating them after they are mined is an expensive process, and despite the significant risks asbestos poses to health, companies that sell cosmetics and other products with talc in them have been trusted to take care of the problem themselves.

Recent investigations and lawsuits, as well as the FDA’s own testing, have forced the agency to recognize that standards for categorizing and measuring cancer-causing asbestos must be established and regulated by the agency.

The Power of the Public

More than 15,000 cases represented by OnderLaw and tens of thousands of other lawsuits have resulted from ovarian cancer and mesothelioma allegedly caused by asbestos in products. These lawsuits, most of which are still ongoing, have put pressure on the FDA to take a harder look at its regulation — or lack of regulation — of asbestos in products.

In 2018, the FDA formed a committee, called the Interagency Working Group on Asbestos in Consumer Products (IWGACP) to identify criteria for testing for asbestos in talc. The testing methods that have been used until now were developed to measure asbestos in large amounts. They weren’t intended to measure the tiny particles of asbestos found in talc — yet those particles have been known for years to be unsafe.

In 2019, cosmetic products sold at retailers Claire’s and Beauty Plus were found to contain asbestos, and were recalled as a result.

In September 2019, using a testing company that has previously testified on behalf of Johnson & Johnson, the FDA found asbestos in Johnson & Johnson Baby Powder. Johnson & Johnson recalled the lot in question, but it has repeatedly denied that testing overseen by the FDA was valid. The FDA has stood by its results.

Thousands of other products have yet to be formally tested under FDA supervision.

In the meantime, the IWGACP has pushed forward to establish regulations.

Classifying Asbestos

IWGACP, made up of experts from seven different federal agencies, put together a preliminary report on what its members believed to be the most effective methods of testing talc, and the hearing allowed for public input to be considered before final recommendations are made.

Among IWGACP’s goals is to establish common classification criteria for asbestos. Many believe that similar particles, called elongated mineral particles (EMPs), should also be classified as asbestos because of their health effects. Currently, some laboratories test for these additional EMPs, and some do not.

In the preliminary report, IWGACP came to the conclusion that all EMPs of similar size and type that cause the same “biological activity, overt toxicity, or epidemiology” should be measured and counted by companies like Johnson & Johnson.

In other words, if mineral particles look like asbestos and act like asbestos in the human body, they should be tested for and eliminated from products.

For consumers, that means additional safeguards against potentially cancer-causing agents in their cosmetics, foods, drugs, dietary supplements, art materials, and ceramics.

Scientists Agree

In the Feb. 4 hearing, nearly all of the scientists and speakers who are not associated with or funded by the talc industry agreed that expanding the classification of asbestos to include all EMPs makes sense. In fact, many pushed for even greater expansion.

In the FDA’s preliminary report, IWGACP suggested that all particles greater than 5 microns in size with certain characteristics be regulated.

Some scientists, including Paul C. Howard, Ph.D., Science Advisor for the FDA’s Office of Regulatory Science argued that particles smaller than 5 microns in length should be tested for as well. Howard referred to a study (Suzuki & Yuen, 2002) that found 89.4% of the asbestos particles found in the lungs of mesothelioma patients were smaller than 5 microns.

Diana Zuckerman, Ph.D., president of the National Center for Health Research, was among the majority of presenters who agreed. “Long thin fibers are not the only ones that are dangerous,” she said, adding, “It’s very important to look at that perspective because these [types of fibers] are in all of our homes and almost all Americans are being exposed to them.”

Leigh O’Dell, an attorney from Alabama law firm Beasley Allen, who acts as OnderLaw co-counsel in thousands of asbestos-related lawsuits, added that fibrous talc, common in talc products, should also be classified, and that only the most accurate technology — not the antiquated and inaccurate methods many companies currently rely on — should be used to test for these fibers.

“The identification of fibers should be based not on academic, geological definitions but the health effects that fibers have in the human body,” she told the panel. “Imaging technology and techniques from the 1960s are outdated and incapable of detecting microscopic fibers of asbestos and similar carcinogens found in cosmetic talc and should be replaced with transmission electron microscopy and other more accurate and sensitive testing protocols. These safety regulations must be upgraded and standardized to protect public health.”

Like our talc team at OnderLaw, O’Dell has become a passionate advocate for those who have suffered ovarian cancer, mesothelioma, and other diseases linked to asbestos. She arrived at the hearing with two former plaintiffs who have suffered tremendous losses. Their testimony punctuated the human element of the importance of regulating asbestos and related particles found in talc products.

Opposition to Asbestos Classification Standards

There were a few naysayers who attended the hearing who stated they believed that the proposed classification standards were not a good idea. In most cases, an obvious affiliation with talc manufacturing or mining industries was evident.

Among them was Andre Nel, professor of medicine at UCLA, who said he did not agree with additional mineral particles being added to those classified as asbestos. UCLA is among several institutions that have partnered with Johnson & Johnson. The company has contributed millions to build UCLA/Johnson & Johnson Health Care Institute.

Another speaker, Dr. Bryan Bandli of RJ Lee Group, a research group paid to provide defense witnesses by Johnson & Johnson, said that not all elongated mineral particles (EMPs) cause cancer. He said more testing is needed before classifying them as asbestos.

What’s Next

Though additional public hearings will likely be held, neither the FDA nor the IWGACP has announced dates or agendas. Public input on the talc meeting was accepted through March 4, 2020.

What is clear to us, however, is that consumers deserve — and are demanding — adequate warnings and regulations so that they can decide for themselves if using a product is worth the risks.

“These are not drugs,” said Laura Plunkett, a toxicologist with Integrative Biostrategies. “These are not things that have benefits. These are something with a risk that should be considered when you are talking about what to tell the consumer about the product.”

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